EP2051683B1 - Perkutane gastrotomiesonde mit aufblasbarem ballon und biologisch abbaubarem verankerungsmittel - Google Patents

Perkutane gastrotomiesonde mit aufblasbarem ballon und biologisch abbaubarem verankerungsmittel Download PDF

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Publication number
EP2051683B1
EP2051683B1 EP07823373A EP07823373A EP2051683B1 EP 2051683 B1 EP2051683 B1 EP 2051683B1 EP 07823373 A EP07823373 A EP 07823373A EP 07823373 A EP07823373 A EP 07823373A EP 2051683 B1 EP2051683 B1 EP 2051683B1
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EP
European Patent Office
Prior art keywords
stomach
pla
biodegradable
abdominal
probe
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
Application number
EP07823373A
Other languages
English (en)
French (fr)
Other versions
EP2051683A2 (de
Inventor
Serge Renaux
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medwin France
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Medwin France
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Publication date
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Publication of EP2051683A2 publication Critical patent/EP2051683A2/de
Application granted granted Critical
Publication of EP2051683B1 publication Critical patent/EP2051683B1/de
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/0053—Means for fixing the tube outside of the body, e.g. by a special shape, by fixing it to the skin
    • A61J15/0061—Means for fixing the tube outside of the body, e.g. by a special shape, by fixing it to the skin fixing at an intermediate position on the tube, i.e. tube protruding the fixing means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0015—Gastrostomy feeding-tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A61J15/0034—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/0053—Means for fixing the tube outside of the body, e.g. by a special shape, by fixing it to the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
    • A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
    • A61B2017/3486—Balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A61J15/0034—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters
    • A61J15/0038—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type
    • A61J15/0042—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/60—General characteristics or adaptations biodegradable

Definitions

  • the present invention relates to percutaneous endoscopic (GPE) and radiological (GPR) gastrostomy probes for direct access to the gastric cavity for enteral feeding.
  • GPE percutaneous endoscopic
  • GPR radiological
  • Percutaneous gastrostomy is currently the gold standard for prolonged enteral nutrition.
  • the simplicity and the speed of the technique, the evolution of the material make that the gastroenterologists or the radiologists are more and more solicited and that the pose is accessible to any endoscopist or radiologist.
  • the probes are usually made of silicone or polyurethane, inert and well tolerated materials. Different calibers or gates are available, small bore probes becoming more easily obstructed.
  • Non-extractable probes, to be replaced, should be cut flush with the cutaneous orifice.
  • the internal device is then pushed into the stomach.
  • the internal retention means can be either recovered by endoscopy, which can be tricky operation or evacuated by natural means with the risk of occlusion and intestinal perforation.
  • the advantage of the non-extractable probes lies in their relatively rigid inner flange which is resistant to an attempted tearing by a patient who is agitated.
  • the extractable probes have a retractable inner collar, or a deflatable retention system, allowing their ablation through the cutaneous orifice by firm traction.
  • the advantage of these flexible systems is to be able to cross a high stenosis, to avoid an endoscopy but they have less resistance to tearing.
  • Extractable silicone probes are suitable for temporary enteral nutrition.
  • Non-extractable or polyurethane probes are more suitable for definitive enteral nutrition or in a restless patient.
  • the invention aims to provide a probe of the kind in question to implement a novel and original solution able to eliminate the aforementioned drawbacks.
  • an endoscopic percutaneous gastrostomy probe which is essentially characterized in that the internal retention means consists of an inflatable balloon, non-biodegradable, associated with separate anchoring means maintained by son, sutured at external points, entirely made of a biodegradable polymer or copolymer whose nature of the polymers used, their dosage and their molar mass in number are determined to obtain a bond which retains its mechanical retention properties up to the adhesion of stomach and abdominal walls between them.
  • the polymer or copolymer used is advantageously chosen from PLA and PLA GA structures.
  • the anchoring means which consist of small anchors, are hard, painful and traumatic for the subject. From where the interest to resorb them because because of their fibrous encapsulation in the time, they can not evacuate by the natural ways.
  • the optimal healing time of the stoma is about 21 days. A too short delay would lead to a bad healing of this one with all the consequences which could result mainly during the introduction of a replacement probe.
  • FIG. single shows, in section, a partial view of a probe provided with a balloon and anchoring means, sandwiching the stomach and abdominal walls.
  • the internal retention means (2) consists of an inflatable balloon (21), non-biodegradable, associated with separate anchoring means (22) held by wires (23), sutured at external points (24), entirely made of a biodegradable polymer or copolymer whose nature of the polymers used, their dosage and their number-average molecular weight are determined in order to obtain a bond which retains its mechanical retention properties until the stomach and abdominal walls are adhesively bonded together.
  • the tubing (1) is generally made of a non-biodegradable biocompatible material such as silicone or polyurethane.
  • biodegradable polymer or copolymer suitable for the medical application in question has been tested by synthesizing various polymers or copolymers in samples, immersed in a model of gastric fluid, having dimensions similar to those of the retention means.
  • internal biodegradable concerned able to degrade within a specified time (in particular between 1 and 3 months), having the physical and mechanical characteristics required in terms of elasticity or hardness, change of shape, swelling due to the setting water, decomposition ...
  • PLA polymers It is in the category of PLA polymers and more advantageously PLA GA that the choice has been made to produce the anchoring means and the suture threads where the shape memory problems do not arise.
  • the invention is not limited to the embodiments described and shown for which the skilled person may provide other variants, particularly in the types of probes used and the constituent materials subsets of said probes to the condition that the anchoring means and the suture son are fully biodegradable.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Pulmonology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Materials For Medical Uses (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Claims (3)

  1. Perkutane Gastrostomiesonde, umfassend:
    a) einen Schlauch (1), der dazu vorgesehen ist, die Magen- (4) und Bauchwand (5) des Patienten zu durchqueren;
    b) ein internes Rückhaltemittel (2), das dazu vorgesehen ist, gegen die innere Seite der Magenwand (4) gedrückt gehalten zu werden;
    c) einen externen Kragen (3), der von dem Schlauch (1) durchquert wird, der dazu vorgesehen ist, gegen die äußere Seite der Bauchwand (5) gedrückt zu werden und in Zusammenarbeit mit dem internen Rückhaltmittel (2) einen Druck auszuüben, der dazu geeignet ist, die Magenwand (4) gegen die Bauchwand (5) im Bereich der Ostomie zu drücken;
    dadurch gekennzeichnet, dass das interne Rückhaltemittel (2) aus einem aufblasbaren, nicht biologisch abbaubaren Ballon (21) besteht, der mit verschiedenen Verankerungsmitteln (22) verbunden ist, die von Fäden (23) gehalten werden, die an externen Punkten (24) vernäht sind, die vollständig aus einem biologisch abbaubaren Polymer oder Copolymer durchgeführt sind, wobei die Art der verwendeten Polymere, ihre Dosierung und die Zahl ihrer Molmasse festgelegt werden, um eine Verbindung zu erhalten, die ihre mechanischen Eigenschaften des Rückhalts bis zur Adhäsion der Magenwand und der Bauchwand untereinander beibehält.
  2. Sonde nach Anspruch 1, dadurch gekennzeichnet, dass das verwendete Polymer des Typs PLA ist.
  3. Sonde nach Anspruch 1, dadurch gekennzeichnet, dass das verwendete Copolymer des Typs PLA GA ist.
EP07823373A 2006-08-02 2007-07-31 Perkutane gastrotomiesonde mit aufblasbarem ballon und biologisch abbaubarem verankerungsmittel Not-in-force EP2051683B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0607074A FR2904531B1 (fr) 2006-08-02 2006-08-02 Sonde de gastrostomie percutanee
PCT/FR2007/001319 WO2008015336A2 (fr) 2006-08-02 2007-07-31 Sonde de gastrostomie percutanee a ballonnet gonflable et a ancrages biodegradables

Publications (2)

Publication Number Publication Date
EP2051683A2 EP2051683A2 (de) 2009-04-29
EP2051683B1 true EP2051683B1 (de) 2011-09-28

Family

ID=37886243

Family Applications (2)

Application Number Title Priority Date Filing Date
EP07823374A Not-in-force EP2054009B1 (de) 2006-08-02 2007-07-31 Perkutane gastrostomiesonde mit aufblasbarem ballon und biologisch abbaubarem verankerungsmittel
EP07823373A Not-in-force EP2051683B1 (de) 2006-08-02 2007-07-31 Perkutane gastrotomiesonde mit aufblasbarem ballon und biologisch abbaubarem verankerungsmittel

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP07823374A Not-in-force EP2054009B1 (de) 2006-08-02 2007-07-31 Perkutane gastrostomiesonde mit aufblasbarem ballon und biologisch abbaubarem verankerungsmittel

Country Status (6)

Country Link
US (2) US20100022969A1 (de)
EP (2) EP2054009B1 (de)
AT (1) ATE526004T1 (de)
ES (2) ES2394387T3 (de)
FR (1) FR2904531B1 (de)
WO (2) WO2008015336A2 (de)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009046164A1 (en) 2007-10-05 2009-04-09 Tyco Healthcare Group Lp Seal anchor for use in surgical procedures
EP2163205A1 (de) * 2008-09-11 2010-03-17 Beat Dr. Wicky Vorrichtung zum Verschliessen von Wunden, insbesondere von Wunden, die durch einen Eingriff mittels eines Trokars in der Bauchdecke entstehen
USD738500S1 (en) 2008-10-02 2015-09-08 Covidien Lp Seal anchor for use in surgical procedures
US9339442B2 (en) 2010-09-27 2016-05-17 Avent, Inc. Multi-balloon dilation device for placing catheter tubes
JP5756734B2 (ja) * 2011-10-20 2015-07-29 日本コヴィディエン株式会社 瘻孔カテーテル
WO2014203259A1 (en) 2013-06-20 2014-12-24 Hadasit Medical Research Services And Development Ltd. Devices and methods for percutaneous endoscopic gastrostomy and other ostomy procedures
US10064649B2 (en) 2014-07-07 2018-09-04 Covidien Lp Pleated seal for surgical hand or instrument access
US9707011B2 (en) 2014-11-12 2017-07-18 Covidien Lp Attachments for use with a surgical access device
US10702304B2 (en) 2014-12-23 2020-07-07 Fidmi Medical Ltd. Devices and methods for ports to living tissue and/or lumens and related procedures
EP3236912A4 (de) * 2014-12-23 2018-07-18 Fidmi Medical Ltd. Vorrichtungen und verfahren für perkutane endoskopische gastronomie und andere ostomie-eingriffe
WO2017109788A1 (en) 2015-12-23 2017-06-29 Fidmi Medical Ltd. Devices and methods for ports to living tissue and/or lumens and related procedures
AU2016344440B2 (en) * 2015-10-31 2020-11-05 Neurovasc Technologies, Inc. Embolus removal device with blood flow restriction and related methods

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3421001A1 (de) * 1983-06-15 1984-12-20 Luciano Luigi Botta Mechanisches ventil zum verschliessen eines kutanen stomas
US5234454A (en) * 1991-08-05 1993-08-10 Akron City Hospital Percutaneous intragastric balloon catheter and method for controlling body weight therewith
US5649959A (en) * 1995-02-10 1997-07-22 Sherwood Medical Company Assembly for sealing a puncture in a vessel
US6186985B1 (en) * 1997-10-03 2001-02-13 Boston Scientific Corporation Gastro-intestinal tube with dissolvable support bolster
US6113609A (en) * 1998-05-26 2000-09-05 Scimed Life Systems, Inc. Implantable tissue fastener and system for treating gastroesophageal reflux disease
EP1503714A4 (de) * 2002-04-22 2007-01-24 Philadelphia Children Hospital Kombinationsvorrichtung mit niedrigem profil für gastrostomie oder jejunostomie mit die granulombildung verhindernden eigenschaften
US8241308B2 (en) * 2002-04-24 2012-08-14 Boston Scientific Scimed, Inc. Tissue fastening devices and processes that promote tissue adhesion
WO2007016371A2 (en) * 2005-07-28 2007-02-08 Akina, Inc. Readily shapeable xerogels having controllably delayed swelling properties

Also Published As

Publication number Publication date
WO2008015337B1 (fr) 2008-07-10
US20090299292A1 (en) 2009-12-03
FR2904531A1 (fr) 2008-02-08
EP2054009A2 (de) 2009-05-06
EP2054009B1 (de) 2012-09-26
WO2008015337A2 (fr) 2008-02-07
WO2008015337A3 (fr) 2008-05-15
US20100022969A1 (en) 2010-01-28
ES2372466T3 (es) 2012-01-20
ATE526004T1 (de) 2011-10-15
WO2008015336A2 (fr) 2008-02-07
ES2394387T3 (es) 2013-01-31
WO2008015336A3 (fr) 2008-04-17
EP2051683A2 (de) 2009-04-29
FR2904531B1 (fr) 2009-06-12

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